Obesity is a major medical problem affecting millions of people worldwide. In addition to the psychosocial stigmas associated with the condition or disease, many medical problems may develop. Hypertension, heart disease, diabetes, hyperlipidemia, degenerative arthritis and certain types of cancer are more common among overweight individuals. For those persons more than forty-five kilograms overweight, the risk of sudden premature death is twelve times higher than normal. Weight loss often results in a significant reduction in risk of these associated problems.
The recommended methods for weight loss are dietary restriction and behavioral modification. However, many persons are unable to achieve significant or sustained results using these methods. Thus, these individuals have turned to other methods of weight loss, including the use of surgical adjuncts to weight control.
In the past, several surgical adjuncts to weight loss have been proposed. Two of those adjuncts are the jejunoileal bypass which although successful, has been abandoned due to high morbidity and gastric stapling which has evolved to the presently successful vertical banded gastroplasty, but which also has significant morbidity.
Another surgical adjunct is described in U.S. Pat. No. 4,246,893. An inflatable balloon is implanted in the abdominal cavity of the body near the stomach. The inflatable gastric device may be employed by inserting a hypodermic needle in an adjustment port located just under the patient's skin. A passage between the adjustment port and balloon permits a gas or fluid to be passed to the balloon, thereby expanding it, and consequently, compress the stomach, reducing its capacity.
Also developed is the intragastric balloon of Garren et al which is disclosed in U.S. Pat. Nos. 4,416,267 and 4,899,747 was shown to be a possibly efficacious remedy for weight control, although random trials have shown no definite increase in weight loss over behavioral modification alone. It is believed that the failure to show any significant increased weight loss may be caused by a high incidence of spontaneous balloon deflation of eighty percent (80%) during the investigation period. Such a high occurrence of balloon deflation would certainly have reduced the balloon's effectiveness. Nevertheless, nearly eighty percent (80%) of the tested patients did report early satiety.
The Garren-Edwards balloon is fully described and explained in several Gastrointestinal Endoscopy publications which are incorporated by reference herein. Specifically, the balloon is a cylindrical bubble of polyurethane inflated with 200 to 220 cubic centimeters of air. The bubble is discharged into the stomach through a large orogastric introducer tube and once in place, the device provides satiety. However, spontaneous deflation of the bubble is prevalent and passage of the deflated device through the pylorus often results in small bowel obstruction which requires surgery. To reduce the complications associated with spontaneous deflation, retrieval of the device was recommended every three (3) months. This requires endoscopic removal and reinsertion of the device if indicated.
A similar device for weight loss is set forth in U.S. Pat. No. 4,485,805 wherein a free-floating, intragastric balloon is placed in the stomach but may be retrieved by endoscopy by a withdrawal loop connected to the balloon. Both the Garrens method and this method (Foster, Jr.) rely greatly on endoscopy which is not only expensive, but also has given rise to complications such as pharyngeal and esophageal perforation and aspiration from its use during deployment and retrieval of the device. Furthermore, the balloon edges and cylindrical shape of the device are believed to have contributed to gastric ulceration or mucosal erosion in some patients. A later-developed smooth, silicone balloon has not been associated with severe gastric mucosal damage and has resulted in increased weight loss.
An even more complex weight loss device is described in U.S. Pat. No. 4,133,315 where the endoscopy tube remains attached to the balloon in the stomach to provide satiety. While this method basically assures retrieval of the balloon upon deflation, the extreme morbidity and discomfort with this method should be selfevident.
Catheters are well known in the medical art, and are commonly used as providing nourishment and for gastrostomy tubes for the purpose of lavaging a patient's stomach. Such gastrostomy devices have been the subject of a number of patents, including U.S. Pat. Nos. 4,315,513 and 4,666,433. It is also known to provide an inflatable balloon as part of the tube so as to hold the tube in place while feeding or lavaging. U.S. Pat. Nos. 4,624,657 and 4,861,334 are just two examples of this. Furthermore, U.S. Pat. No. 2,687,131 provides a catheter having a longitudinal drainage channel and drainage eyes, and inflatable balloon being positioned adjacent the drainage eyes. A second balloon unit is slidably mounted on the tube and is slidably adjustable in holding the tube in place. Nevertheless, the use of catheters for the deployment and retrieval of intragastric balloons has not been discussed in the art pertaining to the intragastric balloon or in the catheter art.
Finally, it is noted that the use of two balloons within a catheter is known in the art. Specifically, U.S. Pat. No. 4,057,065 provides a gastrointestinal tube having an inflatable balloon within the stomach to decompress it and also to provide a seal in the stomach so that any gastric fluids do not spill into the abdominal cavity. A second inflatable balloon is provided at the distal end of the tube which is threaded through the pyloris, jejunum and ligament of Trietz and into the small intestine where it may be inflated to provide both intestinal stent plication and gastric or intestinal decompression.
Notwithstanding the above-described art, the need still exists for a percutaneous intragastric balloon catheter which will provide satiety to a patient without significant risk of morbidity. The need also exists for an intragastric balloon catheter which is easily retrieved and replaced without endoscopy. Furthermore, the need exists for such a balloon to be smooth and have a low ulceration or erosion potential. Even further, the balloon should provide satiety without the risk of obstructing the small intestine upon spontaneous deflation. The need additionally exists for a balloon adjustable in size so as to accommodate individually the volume desired by each patient.